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Sr. Supervisor, QA CIP/SIP Validation

BioMarin Pharmaceutical Inc.

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Location: Novato, CA Posted Date: 4/12/2013 Position Type: Full time Job Code: 13-0146 Required Education: High school or equivalent

Description

BioMarin Pharmaceutical Inc.
At BioMarin, we recognize and value each employee’s contribution toward reaching our corporate mission—to develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them.

Today, with four products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us.

EEO/M/F/D/V
To apply: Visit www.BMRN.com Job Code 13-0146

SUMMARY DESCRIPTION:
This position is responsible for all aspects related to cleaning and steam sterilization validation activities for biological manufacturing processes in a cGMP environment.  This position will coordinate and manage cleaning and steaming process validation projects related to the implementation of new manufacturing processes and changes to existing processes.  The position will primarily focus on the validation activities pertaining to new process implementation, changes, and revalidation, but will also assist users with equipment design, requirements development, process acceptance criteria, and health authority assessments/reports.  The position will assist with change control and regulatory assessments in addition to the presentation of cleaning and steaming validation activities during regulatory agency/partner audits and inspections.  The position organizes and performs validation activities with minimal supervision and will oversee at least two direct report(s) as well as contract validation service providers.  Other responsibilities of this position include: project management/tracking, protocol generation, execution, final summary report generation and other duties as assigned.

RESPONSIBILITIES:
•   Key area of focus pertains to cleaning validation (CIP/COP) and steaming validation (steam sterilization/SIP/Autoclaves).
•   Provide project management oversight for cleaning and steaming process validation activities related to BioMarin’s bulk biologic Drug Substance and Drug Products.
•   Generation of validation master plans.
•   Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions.
•   Assist with preparation of regulatory filings, with answering questions from health authorities, and with presentations of materials during regulatory inspections/partner audits, as applicable.
•   Development and implementation of SOPs/Guideline documents with systemic procedural improvements related to cleaning and steaming validation activities.
•   Determine methods and procedures on new assignments with oversight from manager.  Oversee and manage the activities of sub-teams.
•   Manage, oversee, develop and guide at least two direct reports (and/or contract support personnel).
•   Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin
•   Lead and represent QA Validation in multi-departmental meetings & project teams owned by QA Validation.
•   Identifies and implements improvements to the QA Process Validation systems (department level impact).
•   Coordination of process validation activities performed at multiple locations including contract laboratories, vendor manufacturing/testing facilities and internal BioMarin laboratories.
•   Coordinate process validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.

Other duties as assigned

To apply: Visit www.BMRN.com Job Code 13-0146

Requirements

EDUCATION:
-Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
-Knowledge of industry standards, guidance documents, global requirements related to cleaning validation and/or steam sterilization is required.
Training in project management is preferred.

EXPERIENCE
•   6+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
•   2+ years in a supervisory role.
•   1+ years experience in a position utilizing formal project management.
•   Organizational and management skills to coordinate multi-discipline project groups
•   Ability to speak, present data, and defend approaches in front of audiences and inspectors.
•   Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
•   Experience and participation in regulatory inspections presenting departmental functions in audits or regulatory inspections
•   Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point.  Experience and proficiency with other applications (such as Trackwise, JMP, MS Access a plus).
•   Understanding and familiarity with global regulatory requirements, guidelines, and recommendations for cleaning and steaming process validation expectations.  
•   Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred.

To apply: Visit www.BMRN.com Job Code 13-0146
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